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The Effect of Orthosis and Exercise in Pes Planus

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ClinicalTrials.gov Identifier: NCT03494374
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ju Seok Ryu, Seoul National University Hospital

Brief Summary:
There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.

Condition or disease Intervention/treatment Phase
Pes Planus Device: UCBL orthosis Not Applicable

Detailed Description:

Observation cohort study

We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Orthosis and Exercise in Pes Planus
Actual Study Start Date : December 29, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
Treatment with UCBL and exercise therapy
Device: UCBL orthosis
toe walking exercise
Other Name: Exercise




Primary Outcome Measures :
  1. TM angle [ Time Frame: through study completion, an average of 1 year ]
    Talometatarsal angle


Secondary Outcome Measures :
  1. CP angle [ Time Frame: through study completion, an average of 1 year ]
    Calcaneal pitch angle



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed with pes planus
  • Calcaneal pitch angle < 15 degree

Exclusion Criteria:

  • peripheral neuropathy
  • infection
  • rheumatoid arthritis
  • operation history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494374


Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jusuk Ryu, M.D, PhD    +82-31-787-7739    jseok337@snu.ac.kr   
Contact: Jeehyun Suh, M.D    +82-31-787-6559    suhtwins@hanmail.net   
Sponsors and Collaborators
Ju Seok Ryu

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Responsible Party: Ju Seok Ryu, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03494374     History of Changes
Other Study ID Numbers: B-1701/377-303
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ju Seok Ryu, Seoul National University Hospital:
pes planus
UCBL
exercise
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities